I am certainly not well versed in medical trials or FDA EUAs. However the pumps leading up to these things seem to be pretty solid.
I do however think this has not much shot at getting EUA after the reading I’ve down on it and the fact that COVID isn’t really the media spotlight it once was. With multiple treatments already EUA I’d think you’d have to have pretty strong presentation to pull this off. However everything I’ve read the CEO is bullish as fuck on EUA. I was able to capitalize on the pump up today and will continue to keep an eye on this for the upwards then if doesn’t get the EUA ride puts back down.
From what I have found it was reiterated to a buy with PT of 98. I am probably going to stay away from any puts unless for short term.
This thing has continuously pumped every so often has nearly 50 percent of float shorted. And has a retail following. Any sort of surprise catalyst as noted today this runs. They get some kind of surprise FDA approval at 3 AM or something wouldn’t end up well. With shorts now underwater or close to it AH may take a gamble on some august or later way up the chain strikes 25-30 and see if I can get some premium gains or if they do end up with surprise FDA approval this could really run if shorts start to scramble although that would most likely be short lived with DTC being so easily covered.
Did some quick TA and found that whenever this pops, there’s a sell off the day after. It doesn’t continue to pop. We’re two days away from OPEX so puts for Friday can be the play. I’ll be watching this and grab a put if I like what I see.
TLDR: this study does not look randomized at all and is very unlikely to gain an FDA approval. Seems like the trial was designed to make the drug look more effective than it actually is.
I recommend going through that Twitter feed as it goes into much more detail. I added quite a bit of aug and September puts today as I believe FDA denial is very likely and that decision is expected soon…
On July 13 the FDA granted an EUA for Novavax and their stock has since dropped from ~$70 to $50. Combined with Will’s Culper PDF above and that VERU has continued to pump up to $16 on rumor, I am tempted to buy a few puts.
Something tells me White Diamond Research isn’t the most ethical company… but news nonetheless which probably caused the drop this morning (aside from SPY falling also)
I would be careful with calls, it’s a falling knife now. However it is sitting right on the daily uptrend line so if you’re looking for a call swing now would be the place to take it around that 12.5 mark… with that being said I’ve been tracking this one closely and have made good money playing it both ways and adding to late aug/September OTM puts. IMO this is going to get EUA denial for two main reasons. 1) patient size (n=150) 2) trial design; there were twice as many patient in the placebo group on the ventilator which lead to a high mortality rate in the placebo group…. I believe the FDA will need a larger trial with a better design if VERU hopes to get any sort of approval… EUA decision is due any day now so at the very least hedge whatever position you take, binary events like this the sp is going to move hard one way or the other… Those short reports are pretty good at explaining in better detail why it is unlikely they gain approval at this time… full disclosure I’m holding a decent amount of late aug/sept 10p/8p for which I have already covered my entire cost basis and I’m looking to add a few calls as a hedge right here at the EOD.
I’ve been occasionally taking some calls on it here and there. But haven’t for a week or so. Gets some big runs on any positive news. Shorts are not currently getting blown out like they were when it was up around 17. But this would be good entry in the surprise case it got EUA.
Personally I’ve only been taking 1 or 2 at a time to see if I can catch that surprise. Not really interested in getting blown out buying puts right now if it does get denied as will be plenty of time to ride it down after.
